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“Research Ethics Reimagined” is a podcast created by Public Responsibility in Medicine and Research (PRIM&R), hosted by Ivy R. Tillman, PRIM&R's executive director. Here, we talk with scientists, researchers, bioethicists and some of the leading minds exploring new frontiers of science. This season, we are going examine research ethics in the 21st century -- and learn why it matters to you.
Today's conversation addresses one of the most significant and challenging developments we've seen in years, the widespread and unprecedented termination of federally funded studies across the United States. These cuts have affected tens of thousands of participants, strained research teams, and placed new pressures on IRBs to manage communication, protocol modifications, and participant protections in real time.
Dan McLean:Last month, it was widely reported that the NIH terminated grants for nearly 400 clinical trials this year. When human subjects research trials are stopped, regardless of reason, IRBs work with researchers to follow a clear protocol on how to inform participants and wind down a research trial safely. We are glad to have Dr. Brandon Brown with us today.
Dan McLean:Dr. Brown is a professor of medicine at the Department of Social Medicine, Population, and Public Health at UC Riverside School of Medicine. This year, he was named a fellow of the Hastings Center for Bioethics.
Catherine Batsford:Dr. Brown recently wrote an essay published by the Hastings Center on this topic. In our episode today, Doctor. Brown will help us unpack what these terminations mean for research oversight, how IRBs can prepare, and what institutions can do now to strengthen their policies and processes.
Dan McLean:I'm your host, Dan McLean
Catherine Batsford:And I'm your cohost, Catherine Batsford.
Dan McLean:Dr. Brown, thanks for being with us today.
Brandon Brown, PhD:Happy to be here. Thank you.
Dan McLean:Can you just start with what has happened with respect to the NIH funding that affected a wide range of studies across the country?
Brandon Brown, PhD:Sure. Yeah. The the National Institutes of Health has had a lot of funding cuts. At least we point out in the article that over 74,000 people who are enrolled in biomedical research were cut from those studies, including 2,600 biomedical grants, totaling 9,000,000,000 So this is pretty significant.
Dan McLean:Put this in context, if you could, of the last couple decades of scientific research.
Brandon Brown, PhD:Sure. I think this is unprecedented in the history of U. S. research because while any study could be terminated for for different reasons, and this is kind of in the in the regulations, now this is actually being being enacted. And part of it is due to targeting of of banned words in grants, like accessible or bias or disability, LGBTQ or gender diversity, to name a few.
Brandon Brown, PhD:So kind of the specific targeting of research with different populations, research focused on, like, diversity. This is something that I think is is new, at least junior faculty, junior researchers and a lot of senior researchers. They haven't seen this kind of cuts before with terminations of grants.
Dan McLean:And with these particular human subject research trials that were cut recently, can you speak about what these human subject trials were exploring, what they were attempting to learn?
Brandon Brown, PhD:Everything. Everything and anything. So as long as the research project included some of these banned terms, the whole topic of the research, vaccines, whether it be anything related to HIV or cancer. It's like the the full gamut of any kind of research that was taking place. So there's no one specific type of research project that kind of was, was targeted.
Brandon Brown, PhD:It's just research in general, research that includes some of these banned words. This is what was targeted and this is what was terminated.
Catherine Batsford:You said before that termination can happen. Certainly, is an unprecedented level that's happening right now, but there is usually protocol written into the research. But you mentioned that a lot of the researchers are younger fellows. Is this something that's new for them? It's something that you know, but that maybe that they haven't worked with the IRB on at this juncture?
Brandon Brown, PhD:Yeah, for I mean, for example, in my own case, I'm a full professor. I'm on the IRB at my institution. And I talk with other people on IRBs at other institutions that are at my level, that are also at the junior level. And we haven't seen things like this before. And I would say that in general, researchers such as myself, people who are on the IRB such as myself, we're not really prepared for this kind of unprecedented, scope of study terminations.
Brandon Brown, PhD:And that's one of the reasons why we tackled some of the issues in the article related to informed consent and letting participants know that this is something that could happen now that it's kind of being more more pronounced.
Dan McLean:But in terms of the normal process of informed consent and the normal operations for IRBs, isn't that already part of it to a certain extent that if you're going to be a participant in the human subjects research trial, you're acknowledging that there may be some chance that the trial may not conclude?
Brandon Brown, PhD:Yeah. For example, if if a clinical trial and a lot of clinical trials have a data safety and monitoring board, and if this board decides that the study no longer needs to continue because the results were found to be positive and the study needs to end, or on the flip side, if the study has shown that there is some harm to participants, this is another reason why this study couldn't. But what we're seeing now is we're not we're not seeing any of that. We're just seeing terminations because of kind of the the general topics that are being studied in the research project that include primarily some of these banned words and language that people are saying is not consistent with the kind of federal guidelines and priorities.
Dan McLean:So are you suggesting that moving forward since this has occurred and we're gonna continue to operate in this space for the the near term that that should be an additional highlight to potential participants in human subject research trials that there may be an increased likelihood of this. Is that what you're suggesting?
Brandon Brown, PhD:Yes. I definitely think that participants who are currently in research at this moment, that there should be more communication about that specific possibility of terminations in the informed consent documents. So whereas before, language in there could be about, risk and benefit and clinical trials stopping or starting. Now we we just need to include more language about study terminations could take place at any time for any reason.
Catherine Batsford:How do you think a researcher could balance that realistic consent language and also encourage enrollment? Because I would think that this would definitely deter people.
Brandon Brown, PhD:Absolutely. Yeah. So for for existing participants, for example, if a study is ongoing and we wanted to implement this language about determinations, this would require researchers reaching out or reconsenting participants that are currently enrolled. For for potential participants, we could kind of plan out the consent form beforehand and plan out how we are going to add this termination language. But you're absolutely correct that this may make it more difficult to recruit participants.
Brandon Brown, PhD:It may lead to an additional possible, loss of trust as participants are seeing their colleagues in other studies that are terminated, and now they're thinking about their own participant participation in research and thinking about if they wanna move forward with this, if things could be, kind of stopped at any time. But, absolutely, I think this is gonna be a big challenge for researchers. And since a study could be terminated at any point, this could include like a pre recruitment, so before people are recruited, during recruitment, in the middle of an intervention, or even in follow-up. And each of these points in time for termination kind of has implications.
Dan McLean:As these trials have been cut, what does that mean for pockets and in regions of the country where there is a need to develop more trial sites?
Brandon Brown, PhD:That's a good question. So could you rephrase it?
Dan McLean:Well, it seems like that there's an opportunity to continue these trials in capacity. Do you have ideas of how we can move forward in that respect?
Brandon Brown, PhD:Yeah, I mean, the federal government is terminating grants that are before they start or that are ongoing that are or that are in follow-up, it makes it difficult for new researchers, junior researchers, and senior researchers to be motivated to pursue more research projects. So for instance, in the past, if we were thinking about writing up our proposals and getting our grants reviewed and kind of reaching a certain pay line, which means being in the top x percent of grant applications according to a reviewing body. Now this may not really exist anymore, and this could be kind of demoralizing for for researchers. So if you're talking about kind of filling the gap with with new study sites, this is something that is maybe pretty difficult because of the terminations that are occurring. So we're not really planning for more research.
Brandon Brown, PhD:We're planning for additional research cuts. And we've already seen, I think, in in 2025 research cuts. And in 2026, there's proposals to cut costs for federal health research by, I think, more than half if we're looking at different institutions. So for 2025, I think there was a 50% cut from the National Institute of Minority Health and Health Disparities. And for for 2026, there's a proposed cut across the board of, I think, 40% if that's approved.
Catherine Batsford:Based on all of that, what's the most common harm a participant could experience if a study stops quickly?
Brandon Brown, PhD:Yeah. So I think there's there's different harms, it also depends on the type of study that is being conducted. In in the Hastings article, we talked about implantable devices in in your brain. So if you can imagine if you are a research participant in the study and you have a device implanted in your brain, and then there is a a stop order on the study. So everything needs to stop, including kind of monitoring this device, monitoring your health.
Brandon Brown, PhD:So how do you move forward with that? So I think the the biggest harms are going to be immediately for participants that are in kind of more, above minimal risk research. But the harm to science is kind of more more vast because if research that has been proposed doesn't move forward, then we're not gonna see any of these kind of, like, clinical benefits from from anything that could have been. And that goes to research, but it also goes to, if we're thinking about, for example, students and fellows that were funded for their, you know, tuition fees and stipend on grants to participate in research. If that funding does not exist for them, then we're also talking about fewer rising scientists to kind of lead research in the next generation.
Dan McLean:So it sounds like that you're thinking about this in a couple different ways that by ending trials midstream, it's going to deter other participants from participating in the future and it's going to deter researchers as well from putting the time in to start these trials if they think there's an increased, likeliness they'll end. Is that
Brandon Brown, PhD:kind of what you're saying? Absolutely. And if we're thinking about, for example, junior faculty researchers, sometimes the funding that faculty in general get to conduct research is directly linked to their to their salary. It could mean that people lose their positions in in academia because they don't have the funding to pay themselves.
Catherine Batsford:On a on another side, when you're considering the institutional review boards and their compliance offices
Brandon Brown, PhD:Yeah.
Catherine Batsford:Has this quick termination compiled more work for them? Do they need to go back and then re review these grants and assist the researchers in closing them out?
Brandon Brown, PhD:Yeah. That's that's a good point for the institutional review board. So once a termination notice is communicated with the lead investigator of a project, how is this communicated with the institutional review board? What does it mean if participants are enrolled, but maybe if they haven't been reimbursed for some of their expenses? How do we communicate with this outside termination to the to the IRB?
Brandon Brown, PhD:If we if a study is terminated, and let's say if me as investigator would like to contact the participants, if this communication with participants is not part of the informed consent and not part of the protocol, I might face a protocol violation for reaching out to people to tell them that the study has been terminated. So first and foremost, I do need to go to my institutional review board and tell them what's happened and apply for approval to contact these participants outside of the approved protocol for the study. And absolutely, this will cause kind of, an additional burden on the institutional review board when they receive multiple requests to reach out to participants in different studies. And kind of like public health, institutional review boards at institutions are often overworked and underappreciated.
Catherine Batsford:So in the original protocol, nothing would have been written in there that would have covered this? Or because it's a termination for a different reason that it would have to go then back through the review board?
Brandon Brown, PhD:Yes. Every communication with with a study participant needs to be kind of approved by the institutional review board, and this is part of just ensuring that participants are protected as part of the research process. So even that communication with participants about, termination, maybe there could be faculty or researchers that wanna communicate that termination in a certain way that's not appropriate. So we also need guidance on how to interact with with community members and participants who are part of our research.
Catherine Batsford:Gotcha. Wow, that's made these past couple of months really intense.
Brandon Brown, PhD:I think especially for institutions and institutional review boards that review a lot of clinical research, that review a lot of clinical trials, I think they're the institutions and institutional rewards that are most burdened by this.
Dan McLean:Have you ever personally been involved in research that had to be ended for a reason where you then had to contact the IRB to start that process?
Brandon Brown, PhD:I have not. I have not. I have been talking with my own IRB about this happening because I think every institutional review board has clinical research that that takes place that is maybe the among the above minimal risk research at the institution. Mhmm. So we have been talking about this, in my IRB at the moment.
Brandon Brown, PhD:And, one thing that I was looking at as we were writing this article in the Hastings Bioethics Forum was if there is guidance out there from institutional review boards on what to do and what guidance for researchers on what to do if their research is terminated. And there are some institutional review board websites that talk about that a bit, But, the majority say, hey. If you receive a termination notice, reach out to the IRB. Reach out to the institutional review board. So it makes it kind of difficult for different researchers at different institutions to kind of learn from each other if that information is not out there.
Dan McLean:So if you were involved in a human subjects research trial as the researcher and your funding was terminated, then you would go to the IRB and inform them of that. And then would the IRB inform the participants in the trial or the researcher, or is it a combination of somehow?
Brandon Brown, PhD:Typically, the researcher would be the one to communicate with participants in their own study. It might be difficult for IRBs for institutional view boards to do that because they might not have immediate access to participant identifiers like their emails or their phone numbers to communicate with them. This is something that's on the side of the researchers. We're supposed to have this information. But sometimes even the lead researcher does not have that information.
Brandon Brown, PhD:Sometimes their study staff have that information, which makes like an additional layer of complexity. So study staff may be the primary communicator to individual participants on what should be expected of them. But sometimes it's it's difficult. So if we receive a stop the work order, maybe this impacts our study staff as well, who, you know, you're not being paid to communicate with participants, but we're asking you to do this extra thing that you're not being paid to do to try and protect people in our study. And then this kind of becomes a decision of people if they're willing to do this extra burdensome activity at no cost when they may also be kind of really struggling financially because of losing their positions because of these terminations.
Dan McLean:But what would make this more streamlined from the researcher's perspective? When you write in your article, you ask about who should researchers contact if they receive a cancellation notice. It seems like that's pretty clear that should go right to the IRB. But then the next step, is that what you're asking for more guidance and more clarity on is then what should the researcher communicate to the people participating in the trial?
Brandon Brown, PhD:Yeah. Yeah. So in order for the research to communicate what's going on in a trial, if this communication in this language is not included in the informed consent form and the protocol, this needs to be approved by the institutional review board before that happens. So that's that's, like, the first thing. But the principal investigator of a research project, they also they have study staff.
Brandon Brown, PhD:They have students and fellows. They might have, co investigators and junior faculty and postdocs that are that are working with them. So each of these other kind of key stakeholders and research are also impacted. But for me as a lead researcher, I would probably say that the participants in my study, if the study is terminated, I need to first kind of give all my efforts to try and mitigate and provide a proper communication with them about the termination. But there's a there's a lot more steps and a lot more stakeholders to kind of communicate with apart from the study participants themselves, which I feel we have the highest commitment to.
Catherine Batsford:Yeah. And what happens to their data or any of the work that's gone on before it's been terminated? Are there protocols that are generally in place, or should there be new ones?
Brandon Brown, PhD:There might We might need new protocols to be in place for the data that has already been collected prior to terminations. What I've seen is that any data that has been collected prior to terminations could be retained. And then with a stop kind of work order, everything needs to stop, and you cannot collect any more new data. But what you bring up is is an interesting topic in terms of how do we protect Mhmm. The data that has been already collected from study participants in projects that have been terminated because of they're being targeted for banned words or banned populations and making sure that these study data are protected and that the participants' identifiers are protected in the biggest way possible.
Dan McLean:In your article, you wrote bioethicists can take the lead on developing step by step protocols that researchers should follow when they receive termination notices. Mhmm. With that in mind, what can groups like PRIMR do to help researchers and IRBs in this process?
Brandon Brown, PhD:PRIM&R, for example, could groups like PRIM&R they could develop a protocol on what to do when when a termination notice is received. This might include bringing people from different institutions together, from different stakeholders of the research process together, like researchers, IRB members, students, staff, and participants, and co developing what a protocol should look like. And then once this draft protocol has been created, it could be provided publicly online. And it could be kind of continuously improved iteratively as more of these terminations occur and as more people learn how do we best deal with our research that is being terminated. It seems like a stepwise process, but I think having all the different stakeholders in the room to develop a protocol with a bioethicist maybe at the helm since they might understand a lot of the ethics that's involved in terms of the Institutional Review Board and protecting human participants, I think this would probably be the best way forward.
Brandon Brown, PhD:And then, of course, the the accessible language that will be provided to participants, this is highly important as well.
Dan McLean:And and do you think that could take some of the burden and workload off of individual IRBs?
Brandon Brown, PhD:Absolutely, this could take some of the burden off of the IRBs and this could take some of the burden off of researchers kind of both of these groups. Because if I'm a researcher and I am experiencing my first termination of a research project, I'm going to be like scrambling to find out what to do next, especially if I haven't learned from other people that are receiving these terminations. If I'm an IRB member, at an institution that has not yet received a termination notice for whatever reason, that I am also going to be kind of scrambling on how do I best support participants in the study? How do I best communicate with the investigator and these different stakeholders? So I think having such a protocol would help everybody.
Catherine Batsford:Yeah, it sounds like communication and partnership is needed in these unprecedented moments.
Brandon Brown, PhD:Absolutely. Yeah. And I think probably some some iteration or some kind of some kind of protocols have been developed by different institutions, but maybe these protocols are not yet shared, which means that each person has to kind of come up with their own protocol as they experience this termination. But the better way to do it is just to once we have something, even if it's not great, let's share it, let's improve it, and then, you know, it'll make life easier for all of us in these times where research is being terminated kind of willy nilly.
Catherine Batsford:Really standardize it for the researchers.
Dan McLean:And in that way, it would be more streamlined for, sounds like, if the researcher was going to draft something based on this protocol or this best practice and then submit to your individual IRB, it should help them in signing off on it or making whatever edits are necessary. It sounds like it's where you're going with this.
Brandon Brown, PhD:Yeah, because every kind of change in the protocol, every change in the consent, every communication with a participant requires the the IRB kind of signing off on this. So if there was some language that was created by, you know, a body or at a conference like at at a PRIM&R conference to be a starting point for how to communicate what a termination means. What does this mean for me as a person in this study? And how do I move forward? This this, I think, could really help everyone.
Dan McLean:How long are those notifications to participants? For example, if I was a participant in a trial, it was just three paragraphs, is it a 25 page PDF? What would I be getting?
Brandon Brown, PhD:Are you talking about like the termination language or are you talking about the consent in general?
Dan McLean:No, if I was participating in the human subjects research trial and it stopped for lack of funding and then I would be informed, it sounds like from the researcher and I'm just wondering what that communication would look like and how understandable it would be.
Brandon Brown, PhD:Yeah, because that's one of the big things. So we want to make sure that accessible language is something that is used. And it also depends on what stage of the research project that the study is in. So is this, like, pre recruitment? So or is this during recruitment?
Brandon Brown, PhD:Have people already started to receive an intervention? So the language might change based on where people are. So if the intervention has not taken place yet, maybe we can modify this informed consent to include the termination language. But if you are a person in a study that is terminated and you are in the middle of an intervention, maybe you don't really want to see a 25 page consent as you brought up. Maybe you want to know, Hey, what happens to me?
Brandon Brown, PhD:What am I going to do? I have this device implanted. Are you going to take this out? Are you going to monitor it? Am I going to be okay?
Brandon Brown, PhD:What happens next? So I would hope that a 25 page communication would not be something that people would receive when their study when their participation is terminated in a study because the study is terminated. I think it needs to be very accessible language. It needs to be kind of direct language. But also, some of the communication might be very specific to the study taking place.
Brandon Brown, PhD:So if I'm in a study that is looking, let's say, at HIV testing, and I received a blood draw and I'm expecting to receive my results. If the study is terminated before I receive my results, maybe there needs to be certain language in there that is different than like, let's say, if I have a brain implant. So I think everything needs to be kind of specific to the study. But there should be common language in every study that takes place now that we're experiencing these terminations to let people know that terminations could take place.
Catherine Batsford:I guess I'm going to go back one more time. So a well constructed study that's been approved by the IRB should have those pieces of language built in, correct?
Brandon Brown, PhD:The pieces of language about the study could be terminated at any time for any reason?
Dan McLean:Yeah. You mean prior to the study even beginning? Catherine, is that what you're asking?
Catherine Batsford:I think so. And maybe I'm wrong, but it feels like you have to have some level of communication very early on that it could be terminated.
Brandon Brown, PhD:Yeah. I think what you brought up earlier about the data safety and monitoring board for clinical trials, for example, to say the study may stop because we might find that the intervention is beneficial. We need to stop and give that intervention to everyone. Or it could be that, you know, this intervention seems to be harming people, so we need to stop and then take a better look at this. But in terms of, like, across the board terminations for for any reason, I don't think that this is something that has been included to this point because, we didn't think that this could happen.
Catherine Batsford:Yeah.
Dan McLean:But studies have ended mid course for funding previously. I've got to assume. Are you just saying at this scope? Yes.
Catherine Batsford:Okay.
Brandon Brown, PhD:Yes. And those those studies that have ended kind of midway through previously, maybe they maybe the IRB or the institutional review board and the researchers were kind of struggling on how to interact with the participants in that study. But having one study versus having, like, let's say, you know, 300 clinical trials terminated, these are these are very different things because the scope of the of the impact is going to be so different.
Catherine Batsford:That's true. That's true.
Dan McLean:So you've written for the Hastings Center for Bioethics. What's next on on your mind as you continue to think about this in your work?
Brandon Brown, PhD:Yeah. The next thing that that is on my mind that wasn't covered really in the Hastings Center for Bioethics article, that article focused primarily on the research participants themselves. And this is the most important population that we need to make sure that is protected when terminations occur. But it didn't go into depth among how terminations impact the other stakeholders in research because everybody is impacted in different ways. This also means, you know, people losing their jobs, losing their positions, losing their health insurance, losing their ability to pursue, you know, an educational degree.
Brandon Brown, PhD:And this this kind of impacts science in incredible ways. And sadly, I think this is going to leave It's just going to be difficult for the next generation of science and scientists. We're going to have a lot of making up to do.
Catherine Batsford:Are there I guess as we've talked about better communication and protocols being developed, could there be a moment where research could be done in a more streamlined way?
Brandon Brown, PhD:One thing that will probably come out from this, I hope, is that there will be additional language and informed consent forms about the for people to consider before and during their participation in research because of what's happening in the world with the with the funding cuts. I think people being more aware of what could happen to them in research in terms of if this is cut, what happens to me? What happens to my data? What happens to, you know, this this device that is inside of me? We need to be thinking about this kind of really clearly and broadly, and this moment is teaching us to to do that and to really plan.
Brandon Brown, PhD:It'll probably also be impacting researchers themselves because as we're seeing these these study terminations and as we're seeing, like, the drastic cuts and limitations on future research funding, we need to kind of be nimble and think of other ways on how we're gonna do research without the the funding available that we were able to access before. So I think we're learning a lot and we're going to continue to learn. I don't think I don't know if I would refer to all of that as like as like a positive. But maybe it's the it's the only way forward at the moment.
Catherine Batsford:Yeah. Well, we always try and leave on some kind of positive note, but
Brandon Brown, PhD:Well, maybe one other thing is that this moment is kind of motivating different people to to speak out about about their science and to speak out about the importance of the work that they're doing in research. Whereas before, when when research was already difficult to conduct because of the ability for people to get grants, now it's even even more difficult. But I think more scientists are starting to to kind of speak out about how the elimination or termination of their research projects and of different populations from research is impacting the world. So I think we're going to have more people who do that, and I think that's a good thing.
Catherine Batsford:Yeah. And I think the general understanding of the public that research and public health are intertwined, that this is all for the better good. And that I don't think we're aware of what's going on in the background and how it seems like, oh, this money is just going to what? And now there's direct impact.
Brandon Brown, PhD:Yeah. Yeah. And it's interesting how it also has prompted different kind of innovative researchers. I think I mentioned Amy Noff at Indiana University who created TrialsTracker. So they're they're starting to track the impact of these terminations to have data to show, as as you just mentioned.
Brandon Brown, PhD:So how many people are being impacted by this? So research is no longer something that's kinda, like, out there. We can actually say, hey. Almost 300 clinical trials and 800,000 people are are affected. So this is this is something that makes a difference in in people's lives.
Brandon Brown, PhD:So it's kind of like initiating some some innovation as well as we try to tackle these these cuts.
Dan McLean:In the weeks and months ahead, I think PRIM&R is going to continue exploring this issue. We will be able to have people collectively begin to think more about these issues. I think that will be a good development.
Brandon Brown, PhD:Yeah. I agree. And if you could bring all the different kind of stakeholders to the table for that, I think that's most important. So like, hey, if I'm a participant and I'm in your study and your study is terminated, this is what I wanna hear from you. This is what I need from you.
Brandon Brown, PhD:I think that's gonna be really important.
Catherine Batsford:Absolutely.
Dan McLean:Thank you so much for being with us today and speaking about what you wrote and highlighting this issue. Thank you.
Catherine Batsford:The challenges to abrupt study terminations raise critical questions and issues for IRBs, research administrators, and institutions about preparedness, communication, and our responsibility to participants.
Dan McLean:We hope today's discussion helps you identify opportunities to strengthen oversight and feel more equipped to navigate emerging pressures in the research environment. This is an important topic, and PRIM&R plans to further explore this subject with the PRIM&R community in the months ahead.